RECLAIM 2975-29-085Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295156277), received between Aug 31, 2017 and Jan 26, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Material Deformation

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE RECLAIM MODULAR INSTRUMENTS WERE STRIPPED OUT AND NON-FUNCTIONAL. THE SURGEON HAD TO TRIAL OFF REAL IMPLANTS. THERE WAS NO PATIENT HARM, BUT THE PROCEDURE WAS DELAYED BY NINETY MINUTES DUE TO THE INABILITY TO PROPERLY TRIAL AND STRUGGLE WITH THE INSTRUMENTS. ACTIVITY LEVEL ¿ YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183270 ↗
• MalfunctionMar 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER 85MM BODY AND 40MM NECK HAD BEEN TORQUED TOGETHER, THE NECK STILL SPUN ON THE PROXIMAL BODY TRIAL. THIS MADE DISLOCATING THE HIP AFTER TRIALING DIFFICULT. THERE WAS 2 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630634 ↗
• MalfunctionNov 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT NECK AND BODY TRIALS WOULD NOT LOCK AND WOULD SPIN WHEN TRYING TO REDUCE THE HIP. THERE WAS NO DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689323 ↗
• MalfunctionJul 1, 2024Break; Break

  THIS INSTRUMENT WAS BROKEN DURING USE. IT DID NOT CAUSE ANY HARM OR SIGNIFICANT DELAYS TO THE PATIENT OR THE PROCEDURE. ALL BROKEN PIECES WERE RECOVERED AND THE SURGERY WAS FINISHED WITHOUT ANY FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19648953 ↗
• MalfunctionFeb 13, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT AFTER IMPACTING THE DISTAL RECLAIM STEM IMPLANT, DOCTOR WENT TO TRIAL THE 75MM PROXIMAL TRIAL SHAFT. AFTER ATTACHING THE TRIAL NECK AND TIGHTENING THE NUT, DOCTOR WENT TO REDUCE AND TRIAL THE CONSTRUCT AND THE NECK WOULD SPIN FREELY ON THE PROXIMAL TRIAL SHAFT. UNABLE TO ACHIEVE DESIRED VERSION THEY INSPECTED THE TRIAL SHAFT AND SAW THAT THE THREADS ON THE SHAFT WERE STRIPPED AND DAMAGED. THEY THEN BEGAN TO TRIAL WITH THE 85MM TRIAL SHAFT AND RAN INTO THE SAME ISSUE, WITH THE THREADS UNABLE TO FULLY ENGAGE THE TRIAL NECK. HE THEN MARKED HIS DESIRED VERSION, AND WE OPENED THE PROXIMAL BODY IMPLANT AND IMPLANTED. THERE WAS NO DIRECT DELAY TO THE CASE, THERE WERE NO MISSING PARTS FROM THE IMPLANT AND NO HARM WAS DONE TO THE PATIENT. NO FURTHER INFORMATION ON THIS SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699517 ↗
• MalfunctionOct 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECLAIM 75MM PROXIMAL BODY TRIAL KEPT SLIPPING AND LOOSENING DURING TRIALING. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985186 ↗
• MalfunctionJun 29, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE RECLAIM NECK TRIALS WERE NOT STAYING IN POSITION WHEN SURGEON WAS DOING FINAL TRIALING. THERE WAS NO DELAY IN PROCEDURE AND ALL DAMAGED TRIALS WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231793 ↗
• MalfunctionMar 15, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE RECLAIM NECK TRIALS WERE NOT STAYING IN POSITION WHEN SURGEON WAS DOING FINAL TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550730 ↗
• MalfunctionNov 15, 2022Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INSTRUMENT BROKE DURING SURGERY WITHOUT CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15800464 ↗
• MalfunctionOct 7, 2022Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE TRIAL SPINS ON PROXIMAL BODY DUE TO LOSS OF RETENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15562427 ↗
• MalfunctionSep 19, 2022Break; Break

  IT WAS REPORTED THAT THE 85 TRAIL BODY WAS FOUND TO BE BROKEN DURING THE CASE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446307 ↗
• MalfunctionAug 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN OFF TABLE DIRECT ANTERIOR TOTAL HIP THE ACTIS BROACH PERFORATED THE FEMORAL SHAFT, CAUSING A TROCH FRACTURE. THE DOCTOR ELECTED TO CABLE THE FEMUR AND SWITCH TO A RECLAIM STEM. THE INCISION WAS EXTENDED. THE EXPOSURE WAS MADE DIFFICULT DUE TO THE PATIENTS LARGE ABDOMEN. THE FEMUR WAS PREPPED WITH THE RECLAIM INSTRUMENTS AND A 15X140 STEM WAS PLACED. WHEN REMOVING THE STEM FROM THE INSERTER THE STEM THREADS WERE STRIPPED AND CROSS THREADED. MULTIPLE ATTEMPTS WHERE MADE TO ATTACH THE STEM EXTRACTOR WITH THE RECLAIM INSTRUMENTS AND A UNIVERSAL EXTRACTOR SET. THESE ALL FAILED. THE DOCTOR THEN ELECTED TO SEAT THE PROXIMAL BODY BUT WAS UNABLE TO THREAD THE ASSEMBLY TOOL INTO THE STEM. SURGEON ELECTED TO PLACE THE PROXIMAL BODY AND IMPACT IT MANUALLY. THE LOCKING BOLT WAS ATTEMPTED. IT WAS UNABLE TO THREAD INTO THE STEM. THE DOCTOR REQUESTED THAT ALL THE THREADED INSTRUMENTS THAT WERE USED BE REPLACED. SURGERY TIME WAS EXTENDED BY 2 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209854 ↗
• MalfunctionAug 9, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ALL INSTRUMENTS FOUND STRIPPED IN CENTRAL STERILE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190940 ↗
• MalfunctionJul 5, 2022Break; Break

  IT WAS REPORTED THAT THE INNER SCREW THAT LOCKS ONTO RECLAIM REAMER BROKE WHEN UNSCREWING. NO DELAYS OR PIECES LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14917085 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT THE SURGEON SHEERED OFF INNER SCREW DURING TIGHTENING WITH A NON TORQUE LIMITING WRENCH. ALL PIECES RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14695112 ↗
• MalfunctionMar 8, 2022Naturally Worn; Naturally Worn

  THE GROOVES ARE WORN DOWN CAUSING NECK TRIAL TO SPIN ON THE BODY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13696690 ↗
• MalfunctionJan 11, 2022Naturally Worn; Naturally Worn

  THREADS ON THE TRIAL ARE DAMAGED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13232633 ↗
• InjuryAug 4, 2021Break; Break

  IT WAS ALSO REPORTED THAT DUE TO A BROKEN TEST COMPONENT INSIDE THE INSTRUMENTS, DISLOCATION PROBLEMS OCCURRED AT THE END OF THE SURGERY. FACED WITH THIS PROBLEM, THE SURGEON DECIDED TO REPLACE THE HEAD AND INSERT.

  Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273750 ↗
• MalfunctionJun 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE TRIALING USING THE 85 PROX BODY TRIAL, THE CENTER SCREW BENT AND FELL OUT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975276 ↗
• MalfunctionJan 14, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NECK TRIAL AND THE PROXIMAL BODIES WERE STRIPPED DURING NORMAL USE. THE T-HANDLE HEX SCREW DRIVER WAS TORQUED- LIMITING IN REVERSE AS WELL. A REPLACEMENT FOR THESE 4 ITEMS IS NEED TO THE KNOXVILLE OFFICE. NO SURGICAL DELAY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11171484 ↗
• MalfunctionOct 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 85 BODY TOTAL WON¿T ENGAGE WITH THE STEM. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10756967 ↗
• MalfunctionJul 29, 2020Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION STATES THAT THE INSTRUMENT DID NOT BREAK INTO TWO PIECES.THE GROOVES ON THE PROXIMAL BODY WAS THE FEATURE THAT WAS WORN AND NOT MAKING IT FUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339759 ↗
• MalfunctionMay 13, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN REDUCING THE HIP, NECK TRIAL WOULD NOT LOCK AND WAS SPINNING OUT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053534 ↗
• MalfunctionFeb 4, 2020Break; Break

  IT WAS REPORTED THAT THE RECLAIM NECK SEGMENT (85) SCREW IN HEX WAS BROKEN WHILE TRIALING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9667179 ↗
• MalfunctionNov 22, 2019Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT THE 85 TRIAL BODY SCREW WAS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9364364 ↗